Cleared Traditional

K841374 - HOME PRO VOLUMETRIC INFUSION PUMP

K841374 is the FDA 510(k) clearance for HOME PRO VOLUMETRIC INFUSION PUMP by American Edwards Laboratories. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K841374 · American Edwards Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
318d
Days
Class 2
Risk

K841374 is an FDA 510(k) clearance for the HOME PRO VOLUMETRIC INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on February 15, 1985 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all American Edwards Laboratories devices

Submission Details

510(k) Number K841374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1984
Decision Date February 15, 1985
Days to Decision 318 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 129d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K841374.
PROMINJECT PROGRAMMABLE INFUSION PUMP
K850669 · Pharmacia, Inc. · Apr 1985
STRATOFUSE SYRINGE PIGGYBACK PUMP 1030
K850488 · Strato Medical Corp. · Mar 1985
IMED 980 VOLUMETRIC INFUSION PUMP
K844915 · Imed Corp. · Mar 1985
STRATOFUSE SYRINGE PIGGYBACK PUMP
K844627 · Strato Medical Corp. · Jan 1985
360 INFUSER
K844719 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1985
BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE
K844730 · C.R. Bard, Inc. · Jan 1985